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Field report: Dordan unveils cleanroom thermoforming for medical packaging

Woodstock, IL, a small town 50 miles northwest of Chicago, may be best known as the filming location for the 1993 Bill Murray comedy classic, Groundhog Day. While there’s something to be said about the comfort of same-old, same-old as in the movie where every day repeats itself, that’s not part of nearby Woodstock-based Dordan Manufacturing’s plans for growth. After years of consideration with experience in retail, electronics, automotive, and healthcare packaging, the custom thermoformer committed to adding medical cleanroom packaging capability to its portfolio in 2019.

It’s a bold, but natural step for the nearly 60-year-old, family-owned company, which is ISO 9001:2015 certified for the design, manufacture and distribution of custom thermoformed packaging.

On a visit to Dordan, PlasticsToday met with marketing manager, Chandler Slavin, and her brother Aric Slavin, the company’s newly named general manager, who are third-generation owners. That was followed by a tour of the facility including the spotless new cleanroom that’s fundamental to the company’s future growth.

The two siblings practically grew up in the company run by their father Daniel Slavin, CEO, who had taken over from his father Edward in the early 1970s. Daniel moved the company in a more progressive direction with the introduction of computer-aided manufacturing (CAM)/computer numerical control (CNC) machine-produced tooling and the early adaption of microprocessors.

Now it’s the next generation of Slavins who will help manage the company’s legacy of producing high-quality, highly engineered packaging into a new market that’s growing more than 6% yearly, according to industry reports.

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The side-by-side thermoformers on the main production floor.

“The medical packaging market draws our interest because it aligns with our core capabilities of design and manufacturing excellence and compliments our corporate culture,” says Chandler. “Medical device companies value suppliers that are as committed to their product as they are to theirs. They want a supplier that is nimble and agile, a supplier that has a history of long-standing partnerships with customers built on trust, respect and loyalty.”

Dordan’s thermoforming competency in related markets gives the company a high degree of assurance that the growing pains into a new direction will be minimal.

“We already have healthcare and non-cleanroom medical customers, so we are familiar with the design and quality needs of the industry,” Chandler points out. “By constructing an onsite cleanroom, fully committing to the medical market is a natural progression for us. We have opportunities for cleanroom packaging with these existing customers and are excited to further support their packaging needs for sterile medical devices and kits.”

A stretch goal

However, it is not without challenges that will stretch the company in several directions.

“This new capability requires a significant investment in equipment, facility, training, and talent, as well as the ancillary equipment necessary for validating the process and the part,” explains Aric.

The stringent and unique quality requirements of the medical market mandate tighter quality control than, for example, retail packaging.

“Medical packaging typically requirDordan new syringe trayes a much higher level of attention to detail, starting at the predesign phase all the way through to the completion of the production tooling,” says Chandler. “Each stage of the medical packaging developmental process is very well thought out with a fundamental understanding of our customer’s needs and requirements, and those of the end customer—the healthcare practitioner. Medical thermoformed parts need to be consistently and repeatedly produced, and the design, tooling, and production process needs to be quantified and qualified for part safety, performance, and quality.

“The process and procedures are all about mitigating risk through checks and balances. It’s critical that not only is the cleanroom environment certified, monitored and maintained, but the handling of all materials entering and exiting the cleanroom, and the management of all cleanroom personnel, be done with the goal of minimizing particulates and potential for down-stream bio burden.”

Next: Packaging materials, sustainability and design

The polymer sheets used in thermoforming for medical markets align with the workhorse materials the company has long been intimately familiar with, including polyethylene terephthalate glycol (PETG), polypropylene and amorphous polyester (APET) among others.

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An example of a thin-gauge thermoform for medical markets.

Medical grade PETG is a commonly used medical packaging polymer, says Chandler. “It has superior cutting properties, reducing the potential for fiber hairs and particulate. The blue tint enhances visual inspection that confirms there’s a hermetic seal on the packaging.”

Sheet thicknesses are usually in the range of 30-50 mil, she adds. Packaging types that are molded included component kits and trays.

The broad influence of sustainability in packaging reaches into medical markets, too.

Chandler, who has closely followed sustainable packaging and is a contributing writer on the topic at sister publication Packaging Digest, says, “The two biggest hindrances to recycling packaging are the cost of collection and the cost of sortation. Hospitals are a single-point of collection and have more control over the sortation of material intended for recovery than post-consumer waste streams. Because hospitals dictate what they purchase, there is opportunity to consolidate procurement—for instance, using all PETG packaging trays—in order to generate the quantity of quality material necessary to create the demand for recycling.”Dordan CNC mold maker exterior 720 pixels

Whether for PETG or other polymer, in-house packaging development begins in Dordan’s design department where Engineering personnel use solid model software NX from Siemens PLM Software to create the designs. Material shrinkage during thermoforming, including any asymmetrical change, is one of several factors that are considered.

Dordan can produce a prototype design from scratch in 5-7 business days, depending on complexity. After approval, the NX CAD file is uploaded to one of three new CNC machines (shown above) to produce the aluminum molds.

Those molds are critical for the production floor where Dordan has 12 inline plastics thermoforming machines with the capacity to convert roughly 80-million pounds of plastic material annually. The company’s machinery history has been one of loyalty, according to Aric.

“All of our first eight thermoformers, purchased in the 1970s through the early 1980s, were made by Brown Machinery Corp. (Beaverton, MI),” he says “When it came time to purchase our ninth machine, we investigated other options, and decided on Lyle [now owned by Brown] because of the substantially more robust equipment design. Subsequently, we replaced all our Brown machines with Lyles. These machines continue to perform very well, as they are routinely maintained and upgraded with new components and software.”Dordan production Ranger

Eleven of the Lyle thermoforming lines are located on the main factory floor. Several of the lines are equipped with top-entry style robotic units positioned above the outfeed conveyor that automatically remove the individually formed trays from the web using suction cups; the newest Ranger (seen at right) is about a year old. Tray-from-web separation on the other lines is done manually.

The lone outlier thermoformer is the new Kiefel (Portsmouth NH) Model 78.1 Premium Speedformer, which is in a class by itself: an ISO Class 8 cleanroom that is a fully enclosed and complete hard wall construction. This permanent arrangement is a step up from “soft-style,” modular-build cleanrooms with plastic curtains.

“We wanted a thermoformer that has a large market presence in the medical space,” says Aric of their choice, “and Kiefel is known as a medical thermoformer. Their machines are designed with the high precision and quality that’s needed.”

Featuring Siemens (Munich, Germany) controls, the programmable logic controller (PLC) run machine is more automated than any of its other thermoformers. Unlike the static control panel on the other thermoformers, the Kiefel’s human-machine interface swivels as needed for operator convenience and offers Plexiglas guarding for visibility. To ensure a successful operation, Aric and other staffers attended a weeklong Kiefel training class last October at its New Hampshire headquarters.

Next: A centerpiece of air, space and machine

Dordan Kiefel thermoformer and room The setup for Dordan's newest thermoformer is as much about the machine as the location. The Kiefel thermoformer is housed in a 50ft x 63ft/3,200 sq. ft. isolated room with a cascading air flow design that pushes air from the inside out; the air pressure in the production space is higher than the air pressure in the gowning area and material handling space, which is higher than the air pressure in the factory. The air handler on the exterior of the building brings air in at a certain temperature and level of humidity, where it is then cleaned via high-efficiency (HEPPA) filters before being introduced into the cleanroom. The air circulates through the cleanroom and then exits via the air return handling system.

Dordan’s cleanroom is designed for manufacturing packaging for FDA Class I, II, and III medical devices.

The four-to-six cleanroom operators enter through two doors to the dressing room where they are outfitted with gowns, gloves, over-shoe booties and beard-masks before passing through a third door for entry to the cleanroom. Packaging materials likewise are staged in a room separate from the main plant before entering the cleanroom.

“This has been our most complicated project,” Aric acknowledges. Dordan Aric Kiefel panel

The cleanroom is to be fully certified by around the time this article is published, the timing of which is coordinated with Dordan taking on new business.

“We are currently working with a handful of medical device manufacturers on the design and development of packaging that ensures the safety and effectiveness of their devices,” Chandler explains. “These include startups, established companies bringing new products to market, existing customers that require cleanroom production, and large medical players looking for new cost-competitive suppliers.”

Complimentary growth

The new capability builds on what’s gone before.

“Many of our customers already operate in the healthcare space,” Chandler notes, “and they are pleased that we are enhancing our offerings with an onsite cleanroom. We are expanding business with these customers, which has thus far been an easy transition.”

The company was already feeling a pull from the market for higher-quality medical packaging.

“Dordan has had opportunities in the past to develop medical packaging, but chose not to do so, because we didn’t feel properly equipped,” she discloses “While these opportunities did not necessarily require production in a cleanroom environment, we believe that the design and production of medical packaging requires a completely different mindset. The 18 months needed for cleanroom construction has allowed us to concurrently develop new QC procedures, hire new talent, and procure all of the tools and resources required to offer high quality medical packaging with confidence and transparency.”Dordan thermoformer cleanroom Slavins fun Photo 720 pixels

The company’s expectation is that the addition of cleanroom capabilities will grow sales roughly 5% year-over-year for the first few years of operation without encroaching on current volumes.

“Our customer base as a custom thermoformer is extremely diversified,” says Chandler. “We will continue to nurture this diversification, working to ensure customer satisfaction across all verticals.”

They’ve already had success in attracting new customers.

“I attribute that to our long-standing reputation of quality thermoforming,” says Chandler. “Medical prospects, like most, take comfort in our history of family ownership and operation and our pride for who we are and what we do.”

Even with a solid footprint in the past while proactively stepping into the present, Dordan also anticipates the future: the cleanroom’s size and layout will accommodate a second thermoformer. The integration of past, present and future was how Bill Murray solved his dilemma, which should make for a happy new beginning for Dordan Manufacturing, too. 

 

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